Synergistic Phytoceutical Compositions

ABSTRACT

Phytoceutical compositions for the prevention and treatment of circulatory disorders, feminine endocrine disorders, and dermal disorders. A specific combination of extracts of plants is taught, as well as principles for varying the formulations based on categorizing plants into one of three groups, Energy, Bio-Intelligence, and Organization and selecting several plants from each group. Such combinations have synergistic effects, with minimal side effects.

PRIOR RELATED APPLICATIONS

This application is a divisional application of U.S. application Ser.No. 12/372,628, filed Feb. 17, 2009, which is a divisional applicationof U.S. application Ser. No. 11/924,122, filed Oct. 25, 2007, now U.S.Pat. No. 7,618,639 which is a divisional application of U.S. applicationSer. No. 11/271,940, filed Nov. 10, 2005, now U.S. Pat. No. 7,303,772.

FEDERALLY SPONSORED RESEARCH STATEMENT

Not applicable.

REFERENCE TO MICROFICHE APPENDIX

Not applicable.

FIELD OF THE INVENTION

The invention relates to phytoceutical formulations used to treat avariety of diseases. The formulations are particular combinations ofplants and have synergistic effect in combination. Principles forselecting beneficial formulations are provided.

BACKGROUND OF THE INVENTION

The academic study of medicinal plants for the treatment of diversediseases has been nearly as pervasive as the study of Westernmedicines—The active principles from many traditional medicines havebeen extracted from plants, the curative agents identified and theirmechanisms of action determined. Plant based medicines are typicallywell tolerated, with less severe side effects as well as a smaller rangeof side effects. However, despite the excellent medicinal qualities ofmany plants, they are individually insufficient to take chronicdegenerative diseases into remission. In contrast, while synthetic drugscan be highly effective, their use is often hampered by severe sideeffects. What is needed in the art are better treatment regimes withimproved patient tolerance, while providing sufficient efficacy.

SUMMARY OF THE INVENTION

A number of known beneficial plants were classified according to theircapacity to enhance the three main elements that support overall health:Energy (E), Bio-intelligence (I) and Organization (O). A synergisticeffect is expected when all three categories of herbs (E, I, O) areincluded in a formulation, preferably at least two or three or fourplants from each category. Thus, one embodiment of the inventionprovides a method of selecting additional disease treating formulationsaccording to these principles. Three examples of formulations preparedin this way are provided and additional formulations are being preparedand tested.

Another embodiment of the invention provides an effective, naturalcomposition for treating circulatory diseases. The composition can beused alone, or can be combined with simultaneous use of one or morepharmaceutical compositions. It can be used for the treatment ofdiabetic lesions, obliterative arteriosclerosis, Leriche syndrome(aorto-iliac obliteration), Buerger's disease (thromboangiitisobliterans), thrombophlebitis, chronic venous insufficiency, varicoseveins, varicose ulcers, hemorrhoids, and the like.

Another embodiment of the invention provides a composition for thetreatment of feminine endocrine diseases that can be used alone orcombined with pharmaceuticals. It provides an effective medicine fordiseases such as Polycystic Ovary Syndrome, ovarian cysts, fibrocysticbreast condition, uterine fibroids, dysfunctional uterine hemorrhage,female infertility, premenstrual syndrome, amenorrhea, and the like.

Another embodiment of the invention provides a composition for chronicskin disorders. It can be used alone or combined with pharmaceuticals,and can be used to treat diseases such as psoriasis, dermatitis, skininfections, shingles (herpes zoster), boils, eczema, rash, acne or burn,and the like.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows representative examples of diabetic foot lesions treatedwith the herbaria of Table 1. FIGS. 1A and 1B are photographic evidenceof diabetic foot remissions. FIG. 1C is the length of treatment betweenphotographs shown in FIGS. 1A and 1B. FIGS. 1D to 1F are Dopplerultrasound of blood flow in the toe before and after treatment.

FIG. 2 shows representative examples of PCOS treated with the herbariaof Table 2.

FIG. 3 shows representative examples of psoriasis treated with theherbaria of Table 3. FIGS. 3A to 3C show photographic evidence of severepsoriasis remissions. FIG. 3D is the length of treatment betweenphotographs shown in FIGS. 3A to 3C.

DETAILED DESCRIPTION OF THE INVENTION

“Pharmaceutically acceptable excipients” is used herein according to artaccepted meanings, and includes those ingredients needed to formulate amedicine for mammalian use, including the use of gelatin capsules.

“Synergistic” or “synergy” is used herein to mean that the effect ismore than its additive property. In preferred embodiments, the synergyis at least 1.5, 2, 5, or 10 fold.

By use of “plants,” what is meant herein is that the plant (or thatportion with medicinal activity) is used whole, ground, or as anextract. Also included are purified active ingredients and derivativesthereof. However, it is believed that the best efficacy of plants usedherein is achieved with the use of the entire plant or its extracts,rather than with the use of isolated active ingredients.

Further, although plants are named here according to commonly usednomenclature, with improving taxonomy plants are often reclassified.Whenever a plant is referenced, it includes related species with similaractive ingredients.

The following examples are illustrative only and should not serve tounduly limit the invention.

Example 1 Plant Characteristics—Circulatory Disorders

Angelica sinensis (Dong Quai or Angelica, also Angelica Archangelia,Angelica Pubescens and Angelica Sylvestris) contains terpenes (terpenes,mainly β-phellandrene, with β-bisabolene, β-caryophyllene,β-phellandrene, α- and β-pinene, limonene, linalool, borneol,acetaldehyde, menthadienes, and nitromenthadienes), macrocyclic lactones(including tridecanolide, 12-methyl tridecanolide, pentadecanolide),phthalates (such as hexamethylphthalate), coumarins (especiallyfurocoumarin glycosides such as marmesin and apterin), angelicin andbyakangelicin derivatives (osthol, umbelliferone, psoralen, bergapten,imperatoren, xanthotoxol, xanthotoxin, oxypeucedanin and more), as wellas various sugars, plant acids, flavonoids, and sterols.

Acanthopanax senticosus (Russian Ginseng, Siberian Ginseng, Eleuthero,Devil's Shrub, Touch-me-not, Wild Pepper, Shigoka, Acantopanacissenticosus) contains terpenoids (oleanolic acid), glycosides(Eleutheroside A (daucosterin), B1, C—G, I, K, L, M), phytosterols(β-sitosterol), coumarins (Eleutheroside B1 and B3, isofraxidine),polysaccharides (eleutherans), volatile oils, caffeic acid, coniferylaldehyde, and sugars. Eleuthero has been shown to bind to estrogen,progestin, and mineralocorticoid receptors, and stimulate T-lymphocyteand natural killer cell production. It has activity anti-plateletaggregation activity similar to aspirin, as well as antioxidantactivity. Russian Ginseng contains at least 40 active ingredients.

Rhaponticum carthamoides (Leuzea, or Maral Root) contains a mixture ofcompounds called, “levseins.” Levseins represents a complex of more than10 ecdysterones including 20-beta-ecdysterone, makisterone C,24-dehydromakisterone A, carthamosterone, polypodyne B and ajugasteroneC. Researchers extracted and purified various ecdysteroids fromRhaponticum and found that the ecdysteroids increased the mass of thedeveloping quails in a dose-dependent manner, with the rate of increaseproportional to the ecdysteroids content. The Soviets manufactured asynthetic version of this powerful substance for their athletes withgreat success. Soon after, the U.S. version called Mesobolin circulatedon the underground market for a long time. Incorporation of thisphytomedicine in a composition provides at least 10 active principles ina single therapeutic.

Panax ginseng (Chinese ginseng, panax, ren shen, jintsam, ninjin,Asiatic ginseng, Japanese ginseng, Oriental ginseng, Korean red ginseng)main active components are ginsenosides (Ra1, Ra2, Rb1, Rg1, Rd, Re,Rh1, Rh2, Rh3, F1, F2, F3) and panoxosides, which have been shown tohave a variety of beneficial effects, including anti-inflammatory,antioxidant, and anticancer effects. Results of clinical researchstudies demonstrate that Panax ginseng may improve psychologicalfunction, immune function, and conditions associated with diabetes.Studies indicate that Panax ginseng enhances phagocytosis, naturalkiller cell activity, and the production of interferon; improvesphysical and mental performance in mice and rats; causes vasodilation;increases resistance to exogenous stress factors; and affectshypoglycemic activity. It stimulates hepatic glutathione peroxidase, andthe phytosterols inhibit prostaglandin synthesis. Also it displaysvascular activity because the saponins act like calcium antagonists inthe vasculature. The incorporation of this phytomedicine provides atleast 86 active principles in a single therapeutic.

Panax quinquefolius (American Ginseng, Anchi, Canadian Ginseng, FiveFingers, Ginseng, American, North American Ginseng, Red Berry, Ren Shen,Tienchi) is related to Panax ginseng, but is a distinct species withhigher levels of ginsenoside Rb1 and without ginsenoside Rf. GinsenosideRb1 is believed to limit or prevent the growth of new blood vessels,making it useful to treat tumors. Research suggests that several ofginseng's active ingredients also have a beneficial influence onplatelet aggregation. It also demonstrates an anti-atheroscleroticaction, apparently mediated by a correction in the imbalance betweenprostacyclin and thromboxane. Other studies that have found panaxynol orthe lipophilic fraction to be the most potent anti-platelet agent inginseng, chiefly due to an inhibition of thromboxane formation. Thispossibly occurs via regulation of cGMP and cAMP levels and prolongationof the time interval between the conversion of fibrinogen to fibrin.Ginsenosides have also been shown to be relatively potent plateletactivating factor antagonists. It has antioxidant, anti-inflammatory,and hypolipidemic effects. The incorporation of this phytomedicine intoa composition provides at least 206 active principles in a singletherapeutic.

Pfaffia paniculata (Suma, Brazilian Ginseng, Pfaffia, Para Toda,Corango-acu; also Hebanthe paniculata, Gomphrena paniculata, G.eriantha, Iresine erianthos, I. paniculata, I. tenuis, P. eriantha,Xeraea paniculata) contains active glycosides (beta-ecdysone and threeecdysteroids), pfaffic acids, phytosterols (sitosterol andestimasterol). It also contains saponins. Its germanium content probablyaccounts for its properties as an oxygenator at the cellular level, andits high iron content may account for its traditional use for anemia.This herb increases oxygenation at the cellular level, and it also hasanabolic activity at the muscular and cardiac levels by improving thecontraction of the miocardia and diminishing arrhythmias and stabilizingthe membranes of cardiac cells. The incorporation of this phytomedicineprovides 44 active principles in a single therapeutic.

Rhodiola rosea (Golden Root, Roseroot) consists mainly ofphenylpropanoids (rosavin, rosin, rosarin (specific to R. rosea),phenylethanol derivatives (salidroside, rhodioloside, tyrosol),flavonoids (catechins, proanthocyanidins, rodiolin, rodionin, rodiosin,acetylrodalgin, tricin), monoterpenes (rosiridol, rosaridin),triterpenes (daucosterol, beta-sitosterol), and phenolic acids(chlorogenic and hydroxycinnamic, gallic acids). It also containsorganic acids (gallic, caffeic, and chlorogenic acids) and p-Tyrosol.There are many species of Rhodiola, but it appears that the rosavins areunique to R. Rosea, and it is the preferred species. Its therapeuticproperties include a strong estrogen binding property. It also hasproperties of vasodilatation by activation of mu-opiate receptors inheart muscle, and it is a hypolipidemic, diminishing cholesterol andtriglyceride levels. The incorporation of this phytomedicine provides atleast 20 active principles in a single therapeutic.

Echinacea angustifolia or purpurea (Black Sampson, Purple Coneflower,Rudbeckia, Missouri Snakeroot, Red Sunflower) contains alkaloids(Isotussilagine, tussilagine), amides (echinacein, isobutylamides),carbohydrates (echinacin, polysaccharides (heteroxylan andarabinogalactan), inulin, fructose, glucose, pentose), glycosides(echinacoside), terpenoids (Germacrane), Cichoric acid, betaine,methyl-para-hydroxycinnamate, vanillin, phytosterols, and volatile oils.Echinacea has been the subject of hundreds of clinical and scientificstudies which have primarily used an extract of the root and aerialportions of the botanical. The rich content of polysaccharides andphytosterols in Echinacea are what make it a strong immune systemstimulant. The sesquiterpene esters also have immuno-stimulatoryeffects. Echinacin has also been found to possess anti-fungal andantibiotic properties. This component of Echinacea also hascortisone-like actions which can help promote the healing of wounds andhelps to control the inflammatory reactions. The incorporation of thisphytomedicine into compositions provides at least 70 active principlesin a single therapeutic.

Ganoderma lucidum (Reishi, also G. tsugae, G. valesiacum, G. oregonense,G. resinaceum, G. pfezfferi, G. oerstedli, and G. ahmadii) is an ediblefungus containing bitter triterpenoids (ganoderic acid), β-D-glucan,coumarins, alkaloids and ergosterols. It has vasodilator effect and isuseful in the treatment of angina. It is hypolipidemic andanti-artherotic. It contains at least 32 active principles.

Grifola frondosa (Maitake, Dancing Mushroom; also G. sordulenta,Polyporus umbellatus and Meripilus giganteus) contains the primarypolysaccharide, β-D-glucan in the 1.3 and 1.6 forms. It also containsalpha glucan, lipids, phospholipids, and ergosterol. Animal studiessuggest maitake may lower serum cholesterol and triglycerides.Beta-D-glucan is also recognized as an effective immuno-stimulator. Thissubstance increases the activity of macrophages and otherimmunocompetent cells that destroy tumor cells. The substance alsoimproves the immunological efficiency of these cells by increasingproduction of cytokines IL-1, IL-2 and lymphokines. The final result isan increase of the defenses against infectious diseases. Theincorporation of this phytomedicine provides at least 6 activeingredients for therapeutic use.

Hydrastis canadensis (golden seal, yellow root, turmeric root) containsmainly isoquinoline alkaloids (xanthopuccine, berberine, hidrastine,hidrastanine, beta-hydrastine, canadine and canadaline). These conferanti-inflammatory, bacteriostatic, bacteriocidal, and vasodilatoreffects. In general, its antibacterial action is directed to metabolicinhibition, inhibition of the formation of enterotoxins, and inhibitionof bacterial adhesion. It produces vasodilatation by inhibiting smoothmuscle contraction, and inhibiting platelet aggregation. This plantprovides at least 34 active principles for therapeutic use.

Petiveria alliacea (Anamú, Apacin, Apacina, Apazote De Zorro, Aposin,Ave, Aveterinaryte, Calauchin, Chasser Vermine, Congo Root,Douvant-douvant, Emeruaiuma, Garlic Guinea Henweed, Guine, Guine,Guinea, Guinea hen leaf, Gully Root, Herbe Aux Poules, Hierba De LasGallinitas, Huevo De Gato, Kojo Root, Kuan, Kudjuruk, Lemtewei, Lemuru,Mal Pouri, Mapurit, Mapurite, Mucura-caa, Mucura, Mucuracaa, Ocano,Payche, Pipi, Tipi, Verbena Hedionda, Verveine Puante, Zorrillo)contains Allantoin, Arborinol, Arborinoliso Astilbin, Benzaldehyde,Benzoic-acid Benzyl-2-hydroxy-5-ethyl-trisulfide, Coumarin, DibenzylTrisulfide, Engeletin, alpha Friedelinol, Isoarborinol,Isoarborinol-acetate, Isoarborinol-cinnamate, Isothiocyanates, Kno3,Leridal, Leridol, Leridol-5-methyl Ether, Lignoceric Acid, LignocerylAlcohol, Lignoceryl Lignocerate, Linoleic Acid Myricitrin, NonadecanoicAcid, Oleic Acid, Palmitic Acid, Pinitol, Polyphenols, Proline,trans-n-methyl-4-methoxy, Senfol, β-Sitosterol, Stearic Acid, Tannins,and Trithiolaniacine. Its therapeutic activities includeanti-inflammatory, immune-stimulant and antimicrobial effects. Thisphytomedicine provides about 25 active principles.

Sutherlandia frutescens (Cancer Bush, also Sutherlandia Microphylla)contains L-canavanine, pinitol, GABA (gamma aminobuteric acid), andasparagine. In addition, novel triterpenoid glucoside known as “SU1” hasbeen isolated and characterized. The therapeutic indications includeanti-inflammatory, antioxidant, immuno-modulator, and vasodilatoreffects. This phytomedicine provide at least 5 active principles.

Tabebuia avellanedae (Pau d'arco, Ipê, Lapacho, Tahuari, Taheebo,Trumpet Tree, Tabebuia Ipê, Tajy; also T. ipe, T. nicaraguensis, T.schunkeuigoi, T. serratifolia, T. altissima, T. palmeri, T.impetiginosa, T. heptaphylla, Gelseminum avellanedae, Handroanthusavellanedae, H. impetiginosus, Tecoma adenophylla, Tec. avellanedae,Tec. eximia, Tec. impetiginosa, Tec. integra, Tec. ipe) extracts containdiverse quinone derivatives and a small quantity of benzenoids andflavonoids, including beta-lapachone, xyloidone, tabebuin, quercetin,tecomine, and steroidal saponins. One important ingredient is lapachol,a derivative of which was patented in 1975. It has anti-inflammatory andantibacterial effects. The incorporation of this phytomedicine into acomposition provides at least 32 active principles in a singletherapeutic.

Uncaria tomentosa (Cat's Claw, Peruvian Cat's Claw, Samento, Saventaro,Uña de Gato, also Uncaria guianensis) has several alkaloids includingpentacyclic oxindole alkaloids (POA) (isomitraphylline, isopteropodine,mitraphylline, pteropodine, speciophylline, uncarine F), tetracyclicoxindole alkaloids (TOA) (isorynchophylline, rynchophylline), glycosides(triterpenic quinovic acid glycosides), hirsutine, tannins, catechins,phytosterols (beta-sitosterol, campesterol, stigmasterol), triterpenes,polyphenols, flavanols and oligomeric proanthocyanidins (OPC). It is animmune-stimulant, an anti-inflammatory, vasodilator, and antioxidant. Inlaboratory testing, rynchophylline displays an ability to inhibitplatelet aggregation and thrombosis, suggesting that cat's claw may beuseful in preventing strokes and reducing the risk of heart attack bylowering blood pressure, increasing circulation, inhibiting formation ofplaque on arterial walls and formation of blood clots in the brain,heart and arteries. This phytomedicine provides at least 10 activeingredients.

Petiveria Alliacea (Anamú, Apacin, Apacina, Apazote De Zorro, Aposin,Ave, Aveterinaryte, Calauchin, Chasser Vermine, Congo Root,Douvant-douvant, Emeruaiuma, Garlic Guinea Henweed, Guine, Guine,Guinea, Guinea hen leaf, Gully Root, Herbe Aux Poules, Hierba De LasGallinitas, Huevo De Gato, Kojo Root, Kuan, Kudjuruk, Lemtewei, Lemuru,Mal Pouri, Mapurit, Mapurite, Mucura-caa, Mucura, Mucuracaa, Ocano,Payche, Pipi, Tipi, Verbena Hedionda, Verveine Puante, Zorrillo)contains Allantoin, Arborinol, Arborinoliso Astilbin, Benzaldehyde,Benzoic-acid Benzyl-2-hydroxy-5-ethyl-trisulfide, Coumarin, DibenzylTrisulfide, Engeletin, alpha Friedelinol, Isoarborinol,Isoarborinol-acetate, Isoarborinol-cinnamate, Isothiocyanates, Kno3,Leridal, Leridol, Leridol-5-methyl Ether, Lignoceric Acid, LignocerylAlcohol, Lignoceryl Lignocerate, Linoleic Acid Myricitrin, NonadecanoicAcid, Oleic Acid, Palmitic Acid, Pinitol, Polyphenols, Proline,trans-n-methyl-4-methoxy, Senfol, β-Sitosterol, Stearic Acid, Tannins,and Trithiolaniacine. Its therapeutic activities includesanti-inflammatory, immuno-stimulant and antimicrobial. Thisphytomedicine provides about 25 active principles.

Angelica sinensis (Dong quai or Angelica, also Angelica archangelia,Angelica pubescens and Angelica sylvestris) contains terpenes (terpenes,mainly β-phellandrene, with β-bisabolene, β-caryophyllene,β-phellandrene, α- and β-pinene, limonene, linalool, borneol,acetaldehyde, menthadienes and nitromenthadienes), macrocyclic lactones(including tridecanolide, 12-methyl tridecanolide, pentadecanolide),phthalates (such as hexamethylphthalate), coumarins (especiallyfurocoumarin glycosides such as marmesin and apterin), angelicin andbyakangelicin derivatives (osthol, umbelliferone, psoralen, bergapten,imperatoren, xanthotoxol, xanthotoxin, oxypeucedanin and more), as wellas various sugars, plant acids, flavonoids, and sterols. Thesecomponents have vasodilator activity, increase coronary flow and areantithrombotic. The incorporation of this phytomedicine intocompositions provides at least 70 active principles in a singletherapeutic.

Crataegus oxyacantha (Hawthorn, see also C. monogyna) contains mainlyflavonoids (such as flavonoglycosyls, hyperoside, rutin, flavonol,kaempferol, quercetin) and oligomeric procyanadins (1-epicatechol),which relax arterial expansion to decrease peripheral vascularresistance. Also contains amines (phenyletylamine, tyramine,O-methoxyphenethylamine), flavone (apigenin, luteolin) derivatives,vitexin glycosides, tannins, saponins, and cyanogenetic glycosides. Theincorporation of this phytomedicine into a composition provides at least52 active principles in a single therapeutic plant.

Croton lechleri (Dragon's blood, Sangre de Grado, Sangre de Agua; alsoC. draconoides, C. palanostigma, C. erythrochilus C. salutaris, and C.gossypifolius) produces a distinctive red exudate from its trunkcontaining a considerable amount of secondary plant metabolites, themajority of which are hydrolyzing flavonoids, proanthocyanidins (mainlycatechin, epicatechin, gallocatechin and/or galloepicatechin), as wellas taspine. Other components include the dihydrobenzofuran lignan, sixsimple phenols and their derivatives, three steroids, non-saturatedfatty acids, diterpenoids (hardwickiic acid, bincatriol, crolechinol,crolechinic acid, coberine A, coberine B), and diterpenoids. It healswounds and ulcers of vascular origin. Incorporation of thisphytomedicine into a composition provides at least 23 active principlesin a single therapeutic.

Ginkgo biloba (Ginkgo) contains ginkgolides, bilobalides, bioflavonesand flavone glycosides. Flavone glycosides include quercetin,3-methylquercetin and kaempferol. Quercetin, myrcetin and the rest ofthe flavonoid fraction of the extract have antioxidant and free radicalscavenger effects. The flavonoids diminish infiltration by neutrophilsand increase blood flow. Their antioxidant properties and membranestabilizing activity increase the tolerance to hypoxia. They improvecellular metabolism and protect against the damage caused by ischemia.Ginkgolide B is a powerful inhibitor of platelet activating factor(PAF), binding to its membrane receptors, and antagonizing plateletaggregation. Similarly, it has anti-inflammatory effect by decreasingvascular permeability, and has vasodilator activity by inhibiting theliberation of thromboxane B2 and prostaglandins. Controlled double blindclinical studies conclusively demonstrate the effectiveness of Gingkobiloba in treating peripheral arterial insufficiency. The incorporationof this phytomedicine into a composition provides at least 59 activeprinciples in a single therapeutic.

Hydrocotyle asiatica (Gotu Kola, Bramhi, Pennywort, Marsh Penny,Pennywort; also Hydrocotile asiatica asiatica) contain terpenoids(triterpenes, asiaticoside, brahmoside and brahminosidea, (saponinglycosides) aglycones, asiaticentoic acid, centellic acid, centoic acidand madecassic acid), sesquiterpenes (caryophyllene, trans-B-farnesene),volatile oils (Germacrene D), alkaloids (hydrocotylin), flavones(Quercetin, kaempferol, sesquiterpenes, stigmasterol, and sitosterol),and vallerine, fatty acids, resin, and tannins. It is used to treatchronic venous insufficiency, varicose veins, and venous hypertension.Incorporation of this phytomedicine in a composition provides at least59 active principles in a single therapeutic.

Ruscus aculeatus (Butcher's Broom, Box Holly, Jew's Myrtle, Knee Holly,Kneeholm, Pettigree, Sweet Broom) contains as primary active ingredientsthe steroidal saponins (ruscogenin and neoruscogenin), but otherconstituents have been isolated, including flavonoids, tetracosanoicacid, chrysophanic acid, sitosterol, campesterol, stigmasterol,triterpenes, coumarins, sparteine, tyramine, and glycolic acid. Itsingredients reduce vascular permeability, have anti-elastic propertiesand are vasoconstrictors. The incorporation of this phytomedicine in acomposition provides at least 28 active agents.

Vaccinium myrtillus (European blueberry or bilberry, closely related toAmerican blueberry, cranberry, and huckleberry) contains anthocyanosidessuch as: cianadins, malvidins, petunidins and peonidins. Otheringredients include arbutin, asperuloside, astragalin, beta-amyrin,caffeic-acid, catechin, chlorogenic-acid, cyanadin-3-O-arabinoside,dihydroxycinnamic-acid, epicatechin, epigallocatechin, epimyrtine,ferulic-acid, gallic-acid, gallocatechin, hydroquinone, hyperoside,isoquercitrin, lutein, coumaric-acids, m-hydroxybenzoic-acid,monotropein, myrtillin, myrtillol, myrtine, neomyrtillin,protocatechuic-acid, quercetins, quinic-acid, resinic-acid,syringic-acid, ursolic-acid, and vanillic-acid. Evidence suggests thatanthocyanosides may benefit the retina, as well as strengthen the wallsof blood vessels, reduce inflammation, and stabilize collagen containingtissues. The anthocyanosides improve the activity of enzymes lacticdehydrogenase, glucose-6-phosphatase and phosphoglucomutase, eachinvolved in processes of vascular damage. They reduce the arterialdeposits and stimulate the production of vasodilators, likeprostaglandin (PG12), thus protecting the vascular wall. Anthocyanosideshave strong antioxidant properties, as well. The incorporation of thisphytomedicine into a composition provides at least 63 active principlesin a single therapeutic.

Example 2 Composition—Circulatory Disorders

A particularly preferred composition is shown in Table 1. Ratios reflectthe concentration of active ingredient over the natural state, and theamounts provided are mg of extract. Obviously, the amount should beincreased where the strength is reduced, and vice versa.

TABLE 1 Herbaria Amount Active Agent Ratio (mg) Energy enhancersEleutherococcus senticosus root extract 5:1 53.53 Rhaponticumcarthamoides root extract 12:1  3.85 Panax ginseng root extract 5:110.71 Panax quinquefolius root extract 5:1 32.12 Pfaffia paniculada(Suma) root extract 4:1 21.41 Rhodiola rosea root extract 5:1 9.64Bio-Intelligence modulators Echinacea angustifolia root extract 6:1 1.34Echinacea purpurea root extract 6:1 1.34 Ganoderma lucidum extract 6:132.12 Grifola frondosa extract 10:1  12.85 Hydrastis canadensis rootextract 5:1 38.54 Petiveria alliacea 1:1 64.24 Sutherlandia frutescens1:1 64.24 Tabebuia avellanedae bark extract 4:1 40.15 Uncaria tomentosaroot extract 10:1  16.06 Organization improvers Angelica sinensis rootextract 5:1 64.24 Crataegus oxyacantha fruit extract 5:1 42.83 Crotonlechleri bark resin extract 10:1  10.71 Ginkgo biloba leaf extract 50:1 19.49 Hydrocotyle asiatica plant extract 5:1 64.24 Ruscus aculeatus rootextract 5:1 57.82 Vaccinium myrtillus fruit extract 5:1 38.54 Total 700mg

Example 3 Plant Characteristics—Female Endocrine Disorders

Panax quinquefolius The active principles responsible for itstherapeutic effects are triterpensaponides, of which more than 25different types have been identified. These are denominatedprotopanaxadiols (ginsenosides Rc, Rd, Rb1, Rb2) and protopanaxatriols(ginsenosides-Re, -Rf, -Rg 1, etc.). Panax also contains hydrosolublepolysaccharides (panaxans A-U) and polyacetylenes (ginsenosides A-K,panaxynol and panaxatriol). These substances confer energizingproperties because they increase ATP synthesis. On the other hand theyreduce the secretion of prolactin by increasing dopaminergic activity orby activating dopamine receptors at the anterior hipophysis level.Prolactin is a hormone involved in the appearance of anovulatory cyclesand dysfunctional uterine hemorrhages, menorrhea, mammary fibrocysticcondition, and cyclic mastalgy. The reduction of this hormone explainsthe recovery in the treatment of uterine dysfunctional hemorrhages,Polycystic Ovary Syndrome (PCOS), Ovary Cysts, fibromyomatous uteri, andinfertility.

Pfaffia paniculata Its most important active principles are:Beta-ecdysone and three glycoside ecdysteroids, six different pfafficacids, phytosterols and nortriterpenic glycosides. These substances areenergizing through an increase in ATP synthesis and oxygenation at thecellular level. Also, its phytosterols act as hormone originators, andhave demonstrated effectiveness in the management of diverse conditionsassociated with hormone imbalance, such as: premenstrual syndrome,dysmenorrhea, infertility, dysfunctional uterine hemorrhages, andmenopause.

Rhodiola rosea See above.

Astragalus membranaceus (Huang-Qi) This plant contains three main typesof active principles. Isoflavones, which act as anti-oxidants;astragalans which act as immune-stimulants and anti-inflammatory bystimulating the phagocytic activity of macrophages, of the cytotoxicresponse of T and NK lymphocytes and of the production and activity ofinterferon; and astragalans which act as modulators of thehypothalamus-hypofisis-adrenal axis response.

Echinacea See above.

Dioscorea villosa (Rheumatism root, huesos del dialo, Yuma, Yam, WildYam, Chinese Yam, Mexican Yam, raiz china, and colic root) containssteroid sapogenins (dioscine, dioscorin and diosgenine) as the mainactive principles. Diosgenine can change into ecdysone, pregnenolone,and progesterone, thus, diosgenine is a hormonal precursor, whichcontributes to the neuroendocrine system's modulation. On the otherhand, diosgenine has demonstrated its important pro-apoptotic effects,in the therapy of benign and malign tumors, including mammary andovarian cysts, and uterine fibroids.

Ganoderma lucidum and Grifola frondosa The main active principles ofthese mushrooms are sterols and beta-proteoglucans which bestowanti-inflammatory and immune-modulating properties, because theyincrease the phagocytotic capacity of macrophages and increase theproduction and lifespan of CD4 lymphocytes.

Tabebuia avellanedae contains diverse substances derived from quinones,such as Alfa and Beta lapachone[2-hydroxi-3-(3-metil-2-butenil)-1,4-naftoquinona] and cyclopentanedialdehydes. These confer important anti-inflammatory, pro-apoptotic,antimitotic and cytostatic effects, in treating benign and malign tumorsincluding mammary and ovarian cysts as well as uterine fibroids.

Uncaria tomentosa See above.

Vitex agnus castus (Chaste Tree or chaste berry) An essential oil isextracted from the fruit of this plant, two iridoid glycosides (aucubineand agnuside); a flavone (casticine, which seems to be the primaryactive principle) and 3 minor flavonoids derived from kaempferol andquercetin. These active principles act on the anterior hypofisisdopaminergic-D2 receptors, modulating prolactin secretion. This hormoneis implicated in the appearance of anovulatory cycles and dysfunctionaluterine hemorrhages, menorrhea, mammary fibrocystic condition, andcyclic mastalgy. Vitex agnus castus modulates the secretion of LH fromthe hypofisis, which act on the ovary, starting up the luteal phase andprogesterone secretion. Therefore, Vitex benefits dysfunctional uterinehemorrhages, premenstrual syndrome, PCOS, infertility, ovary cysts,menopause, and fibromyomatous uteri.

Hydrocotile asiatica See above. Also, the active principles includepentacyclic triterpene saponins. The major active principles areasiaticosides and madecassosides. Other minor saponins are thecentelloside, brahmosides, brahminosides and Hydrocotile asiaticasaponins B, C and D. Mucopolysaccharides are the core components of thecellular matrix. The biochemical action of these active principlesreduce the levels of lysosomal enzymes associated with the degradationof mucopolysaccharides. On the other hand, the active agents act on thefibroblasts of the connective tissue, modulating collagen synthesis andinhibiting inflammatory processes. This diminishes the fibrosisprocesses important to fibrocystic mammary and uterine conditions.

Example 4 Composition—Female Endocrine Disorders

A particularly preferred composition is shown in Table 2.

TABLE 2 Herbaria II Amount Active Agent Ratio (mg) Energy enhancersRhodiola rosea root extract 5:1 8.16 Panax quinquefolius root extract4:1 67.97 Pfaffia paniculada (Suma) 4:1 54.37 Bio-Intelligencemodulators Astragalus membrenaceus root extract 5:1 73.41 Echinaceaangustifolia 6:1 20.39 Echinacea angustifolia radix 6:1 3.40 Echinaceapurpurea 6:1 20.39 Echinacea purpurea radix 6:1 3.40 Dioscorea villosa4:1 125.74 Ganoderma lucidum extract 6:1 36.25 Grifola frondosa mushroomextract 10:1  21.75 Tabebuia avellanedae 4:1 67.97 Uncaria tomentosa10:1  24.47 Vitex agnus castus 5:1 57.09 Organization improversHydrocotile asiatica asiatica 5:1 65.25 Total 650

Example 5 Plant Characteristics—Dermal Disorders

Lepidium meyenii (Maca) Its major active principles are: alkaloids(Macaridina, Lepidiline A and B); benzyl-isotiocyanate andglucosinolates; macamides; Beta-ecdysone and phytosterols. Thesesubstances activate ATP synthesis which confers energizing properties.

Rhaponticum carthamoides See above.

Panax ginseng The active principles responsible for its therapeuticeffects are triterpensaponides of which more than 25 different typeshave been identified. These include protopanaxadiols (ginsenosides Rc,Rd, Rb1, Rb2) and protopanaxatriols (ginsenosides-Re, -Rf, -Rg 1, etc.).Panax also contains hydrosoluble polysaccharides (panaxans A-U) andpolyacetylenes (ginsenosides A-K, panaxynol and panaxatriol). Thesesubstances confer energizing properties because they increase ATPsynthesis.

Rhodiola rosea See above. Also, the active principles in this plant(phenylpropanoids, phenylethanol derivatives, flavonoids, monoterpenesand phenolic acids) activate the synthesis of ATP in mitochondria andstimulate reparative energy processes.

Andrographis paniculata (King of Bitters, Chirettta, Kalmegh and Kiryat)Primary active principles associated with Andrographis are: flavonoids,glucosides and diterpenic lactones (andrographolides). These substancesoffer immuno-modulator and anti-inflammatory properties. Even thoughtheir precise mechanism of action is not known, studies suggest thatthey stimulate the immune systems and activate macrophages.

Angelica sinensis contains alkyl phthalides (Ligustilide); terpenes,phenylpropanoids (ferulic acid) and benzenoids. These substancesstimulate the immune system's actions, through diverse lymphokines andhave an anti-inflammatory effect by inhibiting 5-lipoxygenase andelastase, as well as selectively inhibiting 12-(S)-HHTrE production, amarker of cyclo-oxygenase activity.

Astragalus membranaceus See above. Also, Astragalus membranaceusinhibits 5-lipoxygenase and elastase, which indicates that it isvaluable in the management of skin pathologies involving chronicinflammation, such as psoriasis.

Echinacea See above.

Hydrastis canadensis The most important active principles of Hydrastisare isoquinoline alcaloides (Berberina, hydrastina, Hidrastanina,Canadina, Canadalina) which award anti-inflammatory, andimmuno-modulating properties. Berberine inhibits activating protein 1(AP-1), a key factor in transcription the inflammation. It also exerts asignificant inhibitory effect on lymphocyte transformation, so itsanti-inflammatory action seems to be due to the inhibition of DNAsynthesis in the activated lymphocytes or to the inhibition of theliberation of arachidonic acid from the phospholipids of the cellularmembrane. It also has immuno-modulating properties by increasing theproduction of immunoglobulins G and M and stimulating the phagocytoticcapacity of macrophages.

Ganoderma lucidum The main active principles of this mushroom aresterols and beta-proteoglucans that bestow anti-inflammatory andimmune-modulating properties by increasing the phagocytotic capacity ofmacrophages and raising production and lifespan of CD4 lymphocytes.

Uncaria tomentosa see above.

Equisetum arvense (Horse tail) This plant contains abundant mineralsalts particularly silicic acids and silicates. It also containsphytosterols, phenolic acids, flavonoids (mainly quercetin glycosidesand apigenin) and saponins (equisetonin). These active principles blockthe liberation of arachidonic acid, which diminishes inflammation andreduces the proliferation of keratinocytes, as well as inducing G2/Marrest in keratinocytes. The action mechanism is in part due to theinhibition of mitotic kinase activity of p34cd2 and perturbation ofcyclin B1 levels.

Hydrocotile asiatica See above.

Tabebuia avellanedae contains diverse quinone derivatives such as alphaand beta-lapachone, cyclopentane dialdehydes and a small quantity ofbenzenoids and flavonoids, including, xyloidone, tabebuin, quercetin,tecomine, and steroidal saponins. These compounds inhibit keratinocytegrowth and offer anti-inflammatory and antibacterial effects, which areof great importance in the treatment of psoriasis.

Shilajit (Mumiyo) Mumiyo is a natural complex substance, whose activeprinciples are carboxylic acids: (hydroxylated derivatives of Benzoic,Phenylacetic and Hippuric acids), fulvic and humic acids, minerals andamino acids. Of Mumiyo's known properties, the most important ones areits ability to reduce excessive inflammatory reactions and stimulatetissue regeneration. Oral intake of Mumiyo has been used to treat burns,trophic non-healing wounds, eczema, and other skin diseases, such aspsoriasis. It has been established that fulvic/humic acids stimulaterespiration and oxidative phosphorylation in liver mitochondria,increase mechanical resistance of collagen fibers, activate humanleucocytes, reduce excessive inflammatory reactions, and stimulatetissue regeneration.

Shark cartilage This natural compound reduces psoriatic plaquevascularization. It inhibits the proliferation of endothelial cells,competitively blocking the Endothelial Growth Factor at the receptorlevel. It also inhibits tyrosine EGF and EGF-2 dependant phosphorylationas well as the increase of FCE induced permeability. Shark cartilagealso induces endothelial cell apoptosis, by inducing caspase 3, 8 and 9activation, and the liberation of cytochrome c from the mitochondria tothe cytoplasm. Shark cartilage also induces fibrinolitic activity byincreasing the secretion, activity and affinity of Tissue PlasminogenActivator (tPA) for endothelial cells. It also inhibits extracellularmatrix degradation, by inhibiting matrix metalloproteinases MMP-2,MMP-7, MMP-9, MMP-12 and MMP-13. It also stimulates production ofangiostatin.

Schizandra chinensis The major active principles of Schizandra (alsoknown as Wuweizi and Wurenchum) are lignans called schizandrines. Thesesubstances have known hepato-protective and hepato-regenerativeproperties. It maintains the integrity of hepatocyte cellular membranes;increases hepatic levels of ascorbic acid; inhibits NADPH oxidation;inhibits lipid peroxidation at the hepatic microsomal level as well asformation of hepatic malondialdehyde; diminishes production of carbonmonoxide at the hepatic level; has an inductor effect in the enzymaticanti-toxic microsomal hepatic cytochrome P-450; increases biliary flowand the excretion of toxic substances; promotes recovery of hepaticfunctions; induces mRNA formation for the Hepatocyte Growth Factor(HGF); encourages the proliferation of the hepatocyte's endoplasmicsmooth reticula, and accelerates the proliferation of hepatocytes;increases ornithine decarboxylase activity as well as the mitotic index,facilitates DNA synthesis and hepatic proteins; increases levels ofglutathione, glutathione reductase and glucose-6-phosphate, improvingthe regeneration capacity of the liver.

Silybum marianum (Milk Thistle) The active principles of this plant areflavonolignans, including silibine, silicristine and silidianine andisosilibinin collectively known as sylimarin. This compound has thehighest grade of hepato-protective, hepato-generating, andanti-inflammatory activity. The mechanisms which explain itshepato-protector characteristics are diverse and include anti-oxidation,lipid anti-peroxidation, detoxification increase through a competitiveinhibition with toxic substances, as well as protection against thedepletion of glutathione. One of the mechanisms that can explain itshepato-regenerative properties is the increase in protein synthesis,obtained thanks to a significant boost in the formation of ribosomes,DNA synthesis and proteins at the hepatic level, because the activeprinciples join a specific polymerase receptor, stimulating ribosomeformation. Its anti-inflammatory effect is due to the stabilization ofthe mastocytes, the inhibition of neutrophils, a strong inhibition ofleucotriene (LT) synthesis and formation of prostaglandins. Sylimarininhibits intestinal beta-glucuronidase enzymes, thus improvingglucoronization, which is an important step in hepatic detoxification.More corporal toxins are removed via glucoronization than through otherdetox pathways.

Picrorhiza kurroa The most important active constituents are iridoidglycoside picrosides I, II, III and kutkoside, known collectively askutkin. Though less well researched than Silybum, it appears to havesimilar applications and mechanisms of action. When compared withSilybum, the curative efficacy of Picrorhiza was found to be similar, orin many cases superior, to the effect of Silybum. Picrorrhiza possessessignificant antioxidant activity, by reducing lipid peroxidation andfree radical damage. Like sylimarin, it has also an effect on liverregeneration. Picrorrhiza also offers anti-inflammatory effects,inhibiting the infiltration of pro-inflammatory cells. One of its minorcomponents, apocynin exhibits powerful anti-inflammatory effects,without affecting beneficial activities such as phagocytosis, chemotaxisor humoral immunity.

Smilax spp. (sarsaparilla) Its main active principles are: phytosterols,Steroid Saponins, Phenolic acids, Flavonoids and minerals. Thesesubstances adhere to toxins inside the gastrointestinal tract, this wayreducing their absorption by the circulatory stream. On the other handit improves the hepatic and renal excretory functions, facilitating theremoval of toxic substances and waste found in cells, blood vessels andlymphatic system. Also, phytosterols block prostaglandin synthetaseaction, explaining its anti-inflammatory action and use to treatpsoriasis.

Vaccinium myrtillus Angiogenesis appears to be a fundamentalinflammatory response early in the pathogenesis of psoriasis andsignificant abnormalities of vascular morphology and vascularendothelial growth factor (VEGF) play a crucial role in thevascularization of psoriatic plaques. During inflammatory skin diseasessuch as psoriasis, the skin initiates angiogenesis through VEGF and theactive principles of this plant (anthocyanosides, flavonoids, quercetin,tannins, iridoids and phenolic acids) significantly inhibit VEGFexpression by the human keratinocytes, reducing the psoriatic plaque'sangiogenesis.

Example 6 Composition—Dermal Disorders

A particularly preferred composition is shown in Table 3.

TABLE 3 Herbaria Active Agent Ratio Amount (mg) Energy enhancersRhaponticum carthamoides root extract 6:1 0.72 Rhodiola rosea rootextract 5:1 9.66 Szchisandra chinensis 5:1 16.10 Bio-Intelligencemodulators Angelica sinensis 5:1 32.20 Astragalus membranaceus rootextract 5:1 48.30 Echinacea angustifolia 6:1 8.05 Echinacea angustifoliaradix 6:1 1.34 Echinacea purpurea 6:1 8.05 Echinacea purpurea radix 5:11.61 Ganoderma lucidum mushroom extract 6:1 35.78 Hydrastis canadensis5:1 19.32 Lepidium meyenii 5:1 48.30 Panax ginseng root extract 5:116.10 Silibum marianum 5:1 28.98 Shark Cartilage extract 4:1 93.92Tabebuia avellanedae 4:1 67.08 Uncaria tomentosa 10:1  14.49Organization enhancers Equisetum arvense 5:1 22.54 Fulvic Acid-Shilajit65% 1:1 13.95 Hydrocotile asiatica 5:1 42.94 Picrorhiza kurroa(Standardized 4% Kutkin) 5:1 32.20 Smilax officinialis 5:1 72.45Vaccinium mirtyllus 5:1 16.10 Total 650

Example 7 Tolerance Studies

A multicentric, retrospective study was made on 100 healthy volunteerswith the intention of evaluating patient tolerance and side effects ofthe herbaria combination. A capsule containing 700 mg of the herbaria ofTable 1 was administered to each participant three times per day forfive days. During that period they were evaluated by a physician, whoregistered any finding or symptom reported by each subject. The averageage of the participants was 37.4 years with a SD of 8.2 years. Genderwas 55% female, 45% male. The average weight of the subjects was 70kilos with a SD of 12.3 kilos. No undesirable effects were observed in96% of the subjects. Four (4%) subjects reported minor undesirableeffects.

The study showed that herbaria were well tolerated—only minor symptomswere reported by 4 of the 100 subjects. These results showed thenon-toxicity of the herbaria, demonstrating that the formulation issafe. Similar results have been obtained for the PCOS and Psoriasisformulations.

Example 8 Clinical Studies

To evaluate the efficacy of the combination, 110 patients affected withdiverse degrees of lesions of the diabetic foot, were studied by meansof retrospective, multicentric, and descriptive study for two yearduration. Of these patients, 50 had grade III-V lesions, and werediagnosed for surgical amputation of the affected area. The patientswere treated as above, with ten 700 mg capsule of herbaria three times aday, but the treatment was continued on an as needed basis for timesranging from 1.5 months to 10 months. The data is summarized in Table 4.

TABLE 4 Diabetic Foot Lesion Study Number of Clinical QoL* TreatmentPatients Improvement Improvement tolerance Other 110 80.9% 86.4% 97.3%Amputation avoided (89 patients) (95 patients) (107 in 80% of the casespatients) diagnosed for surgery *QoL is Quality of Life

It is significant to note that the herbaria treatment preventedamputation in 40 patients (80% of the population) who were alreadydiagnosed for surgical removal of portions of the foot. In contrast, inthe usual course of standard medical treatment, almost 100% of thesepatients could have expected to have a partial or complete amputation.Thus, these superior results are quite unexpected and clearlydemonstrate the novel and non-obvious qualities of the formulation.

Likewise, 129 patients with chronic varicose ulcers were evaluated. Thetreatment (six 700 mg capsules three times a day) improved ulcers in 79%of the population, and remission was achieved in 21% of the populationin only two months (Table 5). The systemic treatment also significantlyimproved the most frequent symptoms (cramps 71.4%, pain 78%, and edema88.7%). In contrast, most patients with chronic varicose ulcers do notachieve remission under existing pharmaceutical treatments and have highrisk of amputation.

TABLE 5 Chronic Varicose Ulcer Study Number of Clinical QoL TreatmentPatients Improvement Improvement tolerance Remission time 129 79% 81.2%99.2% 2 months in 21% (102 (105 (128 of all patients patients) patients)patients)

In a study of 35 patients with Polycystic Ovary syndrome (PCOS), thetreatment improved pelvic pain in all 20 symptomatic patients, menstrualdisorder (amenorrhea, dysmenorrhea, menometrorrhea, oligomenorrhea) inall 22 symptomatic patients, asthenia and cephalea in all 17 symptomaticpatients, as well as acne and hirsutism in 8 of 9 symptomatic patients.Pelvic echo sonograms revealed that 29 patients (82.9%) experienced atotal disappearance of cysts, while another 6 (17.2%) showed a decreasein cyst size. In contrast, most patients with PCOS do not achievesymptomatic relief without surgical intervention, and very few, if any,have a complete disappearance of cysts (Table 6). The dosage was six 650mg capsules three times a day.

TABLE 6 Polycystic Ovary Syndrome Study Number of Clinical Cyst QoLTreatment Patients Improvement Disappearance Improvement tolerance 35100% 82.9% 100% 100% (29 patients)

Similarly, in a study of 123 patients with severe psoriasis, clinicalremission was observed in 77% of the patients, and almost two thirds ofthe patients achieved clinical improvement in less than 45 days (Table7). In contrast, most patients with severe psoriasis do not achieveremission, but only symptomatic relief with existing pharmaceuticalapproaches. The dosage was seven 650 mg capsules three times a day.

TABLE 7 Severe Psoriasis Study Number of Clinical QoL TreatmentRemission time Patients Improvement Improvement tolerance ≦45 days 12377.2% 66.3% 100% 82.9% (95 patients) (102 patients)

In conclusion, these results indicate that synergistic combinations ofphytoceuticals, scientifically chosen from each category of herbaltonics described in the next section, is suprisingly effective!

Example 9 Principles for Selecting Synergistic Combinations

In order to expand the range of formulations encompassed by theinvention, we have categorized beneficial plants into one of threegroups, each of which should be present for synergistic effect. Theclassifications are Energy, Bio-Intelligence and Organization. Plantsclassified under Energy are associated with ATP synthesis (such as theKrebs cycle, oxidative phosphorylation, beta-oxidation, etc.). Plantsclassified under Bio-Intelligence are those that regulate theneuroendocrine and immunological systems and cellular processes, thuscontrolling the interactions between the various systems in the body.Finally, plants classified under Organization are those that relate tothe structure and function of specific organs. Combinations of plantsfrom these three classification groups have synergistic effect becausethey address each necessary component of cellular and organic health—ineffect they provide the triangle on which healing is fully supported.

A large group of plants were classified (along with some vitamins, etc.)according to this system, based on what is known in the literature abouttheir active ingredients and mode of action. The classification ispresented in Table 8. Table 8 is representative only: based on thecriterion described herein, additional plants can easily be categorizedas their mode of action is elucidated.

TABLE 8 Plant Categories Energy Bio-Intelligence OrganizationAcantopanacis senticosus Agaricus blazei Angelica sinensis Ajugaturkestanica Aloe vera Buplerum chinense Codonopsis pilosulaAndrographis paniculata Cimicifuga racemosa Cordyceps sinensis Annonamuricata Chitin fiber Cornu Cervi pantotrichum Aralia mandschuricaChondroitin sulphate Ilex paraguariensis Astragalus membranaceusCrataegus oxyacantha L-arginine Beta 1.3 glucan Croton lechleri Lepidiummeyenii Beta 1.6 glucan Curcubita pepo Ocimum sanctum Camelia sinensisCurcuma longa Panax ginseng Coriolus versicolor Dioscorea villosa Panaxquinquefolius Echinacea angustifolia Equisetum arvense Pfaffiapaniculata Echinacea purpurea Eucommia bark Ptychopetalum olacoidesGanoderma lucidum Fructus ligustri lucidum Rhaponticum carthamoidesGrifola frondosa Fructus lycii Rhodiola rosea Hydrastis CanadensisFulvic acid Schizandra chinensis Lactoferrin Gentiana lutea Ubiquinone(Coenzime Q10) Lentinus edodes Ginkgo biloba Lobostomon trigonusGlucosamine Morinda citrifolia Glycyrrhiza glabra Petiveria alliaceaGynostemma Polygonum multiflorum radix Harpagophytum procumbens Radixapeoniae alba Herba epimedii Radix polygalae Hydrocotile asiatica Sharkcartilage Linum usitatissimum Sutherlandia frutescens Minerals Tabebuiaavellanedae Mumiyo Turnera aphrodisiaca Opuntia ficus indica Uncariatomentosa Picrorhiza kurroa Valeriana officinalis Plants enzymes Vitexagnus castus Ptycopetalum olacoides Pygeum africanum Rhamnus purshianaRuscus aculeatus Salix alba Sargassum fusiforme Sena alejandrina Serenoarepens Silibum marianum Smilax china Solamun nigrum Tribulus terrestrisUlmus fulva Urtica dioica Uva ursi Vaccinium myrthillus Viburnum sppVitamins

An illustrative example of synergy in medicinal plants is an in vitrostudy that demonstrates how the activity of herbal Berberine alkaloidsis strongly potentiated by the action of herbal 5′-methoxyhydnocarpin(5′-MHC). It shows a strong increase of accumulation of berberine in thecells in the presence of 5′-MHC, indicating that this plant compoundeffectively disabled the bacterial resistance mechanism against theberberine antimicrobial, thus showing the synergy of both substances.Stermitz F R, et al., Synergy in a medicinal plant: antimicrobial actionof berberine potentiated by 5′-methoxyhydnocarpin, a multidrug pumpinhibitor. Proc Natl Acad Sci USA. 2000 Feb. 15; 97(4):1433-7.

We expect to further demonstrate synergistic effect on a molecular scaleby studying the gene expression profile changes in response to variousplant ingredients and combinations thereof. Experiments are alreadyunderway demonstrating the expression profile in response to theformulations. We will be aided in this work because researchers havealready begun studying the expression profiles of various medicinalplants, thus providing a database of knowledge from which to build.E.g., Gohil, et al., mRNA Expression Profile of a Human Cancer Cell Linein Response to Ginkgo Biloba Extract: Induction of Antioxidant Responseand the Golgi System, Free Radic Res. 2001 December; 33(6):831-849.

We may also test combinations of plants for synergistic effects by usingthe mouse model for diabetic lesions, as described in Mastropaolo, etal., Synergy in Polymicrobial Infections in a Mouse Model of Type 2Diabetes Infection and Immunity, September 2005, p. 6055-6063, Vol. 73,No. 9. Briefly, obese diabetic mouse strain BKS.Cg-m +/+Leprdb/J areinjected subcutaneously with mixed cultures containing Escherichia coli,Bacteroides fragilis, and Clostridium perfringens. Progression of theinfection (usually abscess formation) is monitored by examining mice forbacterial populations and numbers of white blood cells at 1, 8, and 22days post-infection. Various plant ingredients and combinations thereofcan be used to show a synergistic effect. Further, the model can be usedto show synergy when the formulations of the invention are combined withexisting pharmaceuticals, such as antibiotics.

1) A method for treating a female endocrine disorder comprising effective amounts of Rhodiola rosea, Panax quinquefolius, Pfaffia paniculada, Astragalus membrenaceus, Echinacea angustifolia, Echinacea angustifolia radix, Echinacea purpurea, Echinacea purpurea radix, Dioscorea villosa, Ganoderma lucidum, Grifola frondosa mushroom, Tabebuia avellanedae, Uncaria tomentosa, Vitex agnus castus and Hydrocotile asiatica, together with pharmaceutically acceptable excipients. 2) The method of claim 1, comprising the composition of Table
 2. 